The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase) for adults with high-risk smoldering multiple myeloma, making it the first and only approved treatment for this slow-growing type of multiple myeloma.
People with smoldering multiple myeloma typically don’t show visible symptoms, but the condition carries a high risk of progressing to fully developed multiple myeloma.
Patients “will now be able to receive this treatment before they progress to active multiple myeloma, giving us the opportunity to shift the treatment paradigm and bring hope to people who are impacted by this disease,” Jordan Schecter, MD, vice president of research and development in multiple myeloma and oncology at Johnson & Johnson Innovative Medicine, said in a company press release.
Darzalex Faspro is a Johnson & Johnson subcutaneous injection co-formulated with Halozyme’s Enhanze technology to allow faster and easier delivery under the skin. “The approval expands the indications for Darzalex Faspro with Enhanze, further solidifying its role as a cornerstone therapy across all stages of multiple myeloma,” Helen Torley, Halozyme’s president and CEO, said in a company press release.
Multiple myeloma is a type of blood cancer that arises from the abnormal and uncontrolled growth of plasma cells, a type of immune cell that normally produces antibodies to help fight infections. It starts in the bone marrow — the spongy tissue at the center of the bones where blood cells are made — and can spread throughout the body, causing various myeloma symptoms.
Giving the immune system a hand
Smoldering multiple myeloma is characterized by the buildup of myeloma cells that have not yet progressed enough to cause organ damage. While some people with the condition never develop active myeloma, up to 75% eventually do.
Darzalex Faspro contains daratumumab, the active ingredient in Darzalex. This antibody binds to CD38, a protein highly expressed on abnormal plasma cells. By binding to CD38, daratumumab helps the immune system recognize and destroy the abnormal cells. Darzalex Faspro also includes hyaluronidase, an enzyme that facilitates its administration under the skin and enhances absorption into the body.
The FDA’s decision to approve the treatment was based on results from AQUILA (NCT03301220), a Phase 3 clinical trial that compared Darzalex Faspro to active monitoring, the standard of care for smoldering myeloma. Darzalex Faspro reduced the risk of progression to active multiple myeloma or death by 51%.
“Data from the AQUILA study reinforce the significant impact Darzalex Faspro continues to have for patients,” Schecter said.
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